Indonesia BPOM Product Licensing

We are your partners for BPOM registration from initial application & approval to full-scale operations.

[Live] Indonesia BPOM2025-01-15T10:28:40+08:00

As a business planning to introduce products into the Indonesian market, securing BPOM approval is essential to comply with Indonesia’s regulatory standards and ensure consumer safety. Companies failing to meet BPOM requirements may face penalties, product recalls, or legal action, while unregistered products risk being barred from sale and distribution.

At Paul Hype Page Indonesia, we specialize in navigating the BPOM approval process for food, cosmetics, pharmaceuticals, and other regulated products. Our team evaluates your product’s compliance, provides clear guidance, and manages all necessary documentation and submissions. By streamlining the approval process, we help you avoid delays and ensure a successful market entry. Trust our expertise to support your business expansion and confidently launch your products in Indonesia.

What is BPOM?

A BPOM license is essential for businesses introducing food, cosmetics, pharmaceuticals, or health supplements into the Indonesian market. It ensures compliance with Indonesia’s strict safety and quality standards, granting legal approval to sell and distribute products. With a BPOM license, businesses can build consumer trust, enhance brand credibility, and access a thriving local market. It also facilitates smoother import processes and regulatory compliance, ensuring seamless operations for both domestic and foreign companies. As a vital step for market entry, obtaining a BPOM license is key to achieving long-term success in Indonesia’s competitive landscape.

Related Read: What Are The Licenses under BPOM in Indonesia?

What Are the Types of BPOM Licenses in Indonesia?

In Indonesia, BPOM (Badan Pengawas Obat dan Makanan) offers various types of licenses to regulate and certify products entering the market. These licenses are tailored to ensure compliance with Indonesia’s strict safety and quality standards across different product categories. BPOM categorizes product registrations into four primary types, each tailored to specific product groups and regulatory requirements.

Food Products

The food product registration ensures that all imported or locally manufactured food items meet Indonesia’s safety and quality standards. This certification is essential for businesses seeking to market their products, with approvals covering aspects such as nutritional content, packaging, and labeling compliance.

Cosmetic Products

Cosmetic product registration is designed to certify that skincare, makeup, and personal care products are safe for consumer use. This process includes testing for prohibited substances and verifying labeling requirements, allowing businesses to sell their products confidently in Indonesia.

Health Supplements & Herbal Products

This category covers products like vitamins, minerals, and herbal remedies. Registration involves assessing efficacy claims and ensuring compliance with safety standards, allowing businesses to market health-focused products while fostering consumer trust.

Pharmaceutical Drugs

Pharmaceutical registration focuses on the safety, efficacy, and quality of medicines intended for the Indonesian market. This rigorous process includes clinical data review and manufacturing inspections, ensuring that only approved drugs reach consumers.

Our Indonesia BPOM Licensing Services

With years of experience in various applications in Indonesia, we understand the challenges businesses face in navigating regulatory requirements. Our proven expertise ensures a smooth and hassle-free process for obtaining BPOM approvals across various product categories, working with your business every step of the way. Let Paul Hype Page Indonesia provide personalized guidance, simplifying every step and giving you the clarity and confidence to launch your products successfully in Indonesia.

Food Products

We streamline the process of registering food products with BPOM, ensuring compliance with Indonesia’s safety and labeling standards. From document preparation to final approval, we make it easy to bring your food products to market.

  • Safety and Nutritional Standards: Ensures that food products meet Indonesia’s food safety and nutritional content regulations.
  • Labeling Compliance: Requires labels in Bahasa Indonesia with clear details about ingredients, expiry dates, and nutritional value.
  • Testing Requirements: Includes testing for contaminants, shelf-life stability, and compliance with health regulations.
  • Market Authorization: Grants legal approval to sell food products in Indonesia, enhancing consumer trust.

30 – 60 Business Days

Estimated Application Timeline*

*Timeline may vary based on client responsiveness, speed of document submission & other unforeseen circumstances.

Cosmetic Products

We handle the entire cosmetic registration process, verifying safety and compliance with BPOM regulations. Whether it’s skincare or makeup, we ensure your products meet all requirements for successful distribution in Indonesia.

  • Prohibited Substance Screening: Ensures cosmetics are free of harmful or banned ingredients.
  • Ingredient Disclosure: Requires full disclosure of all active and inactive ingredients in compliance with BPOM regulations.
  • Labeling Standards: Mandates proper labeling with usage instructions, warnings, and product origin in Bahasa Indonesia.
  • Safety Testing: Includes dermatological tests for safety and skin compatibility, particularly for sensitive products.

30 – 90 Business Days

Estimated Application Timeline*

*Timeline may vary based on client responsiveness, speed of document submission & other unforeseen circumstances.

Health Supplements & Herbal Products

We simplify the registration of health supplements and herbal products, ensuring they meet BPOM’s safety and efficacy standards. Let us guide you through the process, so you can confidently market your products.

  • Efficacy Validation: Requires scientific or traditional evidence to support health claims made by the product.
  • Safety and Purity: Ensures products are free from harmful substances and meet quality standards for consumption.
  • Labeling for Claims: Regulates the accuracy of health claims and product information to prevent misleading consumers.
  • Compliance with Testing Protocols: Involves lab tests for active ingredient consistency and safety.

30 – 90 Business Days

Estimated Application Timeline*

*Timeline may vary based on client responsiveness, speed of document submission & other unforeseen circumstances.

Pharmaceutical Drugs

We assist in navigating the stringent requirements for pharmaceutical registration, ensuring your medicines meet BPOM’s quality, safety, and efficacy standards. Our expertise makes the approval process seamless and efficient.

  • Clinical Data Review: Requires comprehensive clinical trial data to prove safety, efficacy, and quality.
  • Manufacturing Standards: Mandates compliance with Good Manufacturing Practices (GMP) for production facilities.
  • Detailed Documentation: Requires submission of a Certificate of Analysis (CoA), stability studies, and other technical dossiers.
  • Rigorous Evaluation Process: Involves an extensive review of safety profiles, including potential side effects and contraindications.

6 – 12 Months or Longer

Estimated Application Timeline*

*Timeline may vary based on client responsiveness, speed of document submission & other unforeseen circumstances.

Experienced Business Consultants

Our 2 Decades of Proven Expertise Will Guide Your Business

With over 20 years of collective experience across Singapore, Malaysia, Indonesia, and Hong Kong, we have facilitated over 2,000 successful regulatory applications across diverse sectors. Our proven expertise can help you achieve BPOM licenses in Indonesia, reflecting our commitment to delivering results. As trusted advisors, we leverage in-depth market knowledge and strategic networks to help businesses navigate regulatory complexities and achieve success in competitive markets.

Senior Consultant Rachel at Paul Hype Page Indonesia
Kickstart your Indonesia BPOM License Application via
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or
Request a Quote
with our consultant today!

General BPOM Licensing Application Timeline

  • Preparation Phase
    5-15 Business Days
  • Initial Review by BPOM
    5-20 Business Days
  • BPOM Warehouse Checking
    7-14 Business Days
  • Laboratory Testing
    10-30 Business Days
  • BPOM Evaluation & Approval
    15-45 Business Days
  • License Issuance
    5-10 Business Days

At Paul Hype Page, we specialize in simplifying the Indonesia application processes, offering expert guidance to help businesses meet Indonesia’s regulatory standards. Whether you’re registering food, cosmetics, supplements, or pharmaceuticals, our experienced team provides tailored solutions to suit your needs.

From document preparation to liaising with authorities, we handle the entire application process with precision and care. Trust us to streamline your BPOM approval, ensuring a smooth and efficient experience as you bring your products to market in Indonesia.

Kickstart your Indonesia BPOM License Application via
WhatsApp
or
Request a Quote
with our consultant today!

Indonesia BPOM License Application Requirements and Best Practices

With extensive experience in facilitating applications in Indonesia, we understand the complexities businesses face when navigating regulatory requirements in Indonesia. Our expertise ensures a seamless process for obtaining BPOM approvals. Trust us to provide personalized guidance, simplifying every step and equipping you with the confidence to bring your products to market effortlessly.

Requirements

Food Products

  • Company and Product Documentation: Valid business license (NIB), food production certificate, or import license (if applicable). Product name, ingredients, specifications, nutritional analysis, and manufacturing process details.
  • Packaging and Labeling: Label in Bahasa Indonesia with product name, nutritional content, expiry date, usage instructions, and barcode for traceability.
  • Laboratory and Supporting Documents: Certificate of Analysis (CoA), stability test results (if applicable), import documentation, and Halal certification (if required).

Cosmetic Products

  • Company and Product Documentation: Valid business license (NIB), GMP certification for manufacturers, product name, category, ingredients, and specifications (e.g., pH levels).
  • Packaging and Labeling: Label in Bahasa Indonesia with usage instructions, warnings, batch number, and barcode for traceability.
  • Testing and Supporting Documents: Safety testing results, CoA for ingredients, import documentation, and supplier agreements (if imported).

Health Supplement and Herbal Products

  • Company and Product Documentation: Valid business license (NIB), GMP certification for manufacturers, product name, active ingredients, health benefits, and stability studies.
  • Scientific and Supporting Data: Evidence of efficacy (e.g., clinical trials or literature), CoA for raw materials and finished products, import documentation, and Halal certification (if applicable).
  • Packaging and Labeling: Label in Bahasa Indonesia with dosage instructions, health warnings, and barcode for traceability.

Pharmaceutical Products

  • Company and Product Documentation: Valid business license (NIB), GMP certification for manufacturing facilities, product name, dosage form, active and inactive ingredients, and manufacturing process details.
  • Clinical and Scientific Data: Clinical trial results, toxicology reports, and pharmacological data to demonstrate safety, efficacy, and quality.
  • Packaging and Supporting Documents: Label in Bahasa Indonesia with dosage instructions, safety warnings, barcode, CoA, stability test results, and import documentation (if applicable).

Important Note!

A registered warehouse is a mandatory requirement for clients applying for a BPOM license in Indonesia. The warehouse serves as the official storage location for imported or locally manufactured products and must comply with BPOM regulations. Clients must provide documentation confirming the warehouse’s location, ownership or rental agreement, and its suitability for storing the specific product category. Ensuring a compliant and properly registered warehouse is critical to avoid delays in the BPOM approval process.

Best Practices

Ensure You Have an E-FIN

Ensure You Have an E-FIN

An E-FIN (Electronic Filing Identification Number) is essential for registering on BPOM’s PSP Online platform, linking the client’s NPWP to the system. Confirm the client has an NPWP and assist in obtaining an E-FIN if needed to enable PSP Online access.

Prepare Accurate and Complete Documentation

Prepare Accurate and Complete Documentation

Ensure all required documents, such as product specifications, GMP certification, and labeling designs, are accurate and comply with BPOM’s standards to avoid delays in the application process.

Conduct Pre-Submission Testing

Conduct Pre-Submission Testing

Perform laboratory testing and obtain a Certificate of Analysis (CoA) for raw materials and finished products to confirm compliance with BPOM safety and efficacy requirements.

Optimize Packaging and Labeling

Optimize Packaging and Labeling

Ensure packaging and labels meet BPOM standards, including product name, usage instructions, warnings, and barcodes, all presented in Bahasa Indonesia.

Monitor PSP Online Regularly

Monitor PSP Online Regularly

Use PSP Online to track application progress, respond to BPOM queries promptly, and provide any additional documents or clarifications as required.

Anticipate Timelines and Plan Accordingly

Anticipate Timelines and Plan Accordingly

Plan for processing times that vary by product category, from 1–2 months for food products to 12 months for pharmaceuticals, and prepare for potential re-submissions.

Stay Updated on BPOM Regulations

Stay Updated on BPOM Regulations

Regularly review updates and announcements from BPOM to ensure compliance with any new requirements or changes in the registration process.

Work with Experienced Consultants

Work with Experienced Consultants

Navigating BPOM regulations can be complex. Partner with consultants, like Paul Hype Page Indonesia who specialize in BPOM applications and understand the regulatory landscape in Indonesia. Their expertise can minimize errors, delays, and complications.

Hover Over Me!

It is essential to provide detailed and accurate information about the business and product, including the company name, address, contact information, and legal registration details such as the NIB (Nomor Induk Berusaha). This ensures transparency and facilitates the verification process during BPOM registration.

Additionally, comprehensive details about the product must be included, such as product name, composition, intended use, manufacturing process, and packaging specifications. These details enable BPOM to assess compliance with safety, quality, and labeling standards, ensuring the product is suitable for distribution in Indonesia.

Frequently Asked Questions

Navigating BPOM licensing in Indonesia can be challenging, especially if you’re unfamiliar with local regulations and requirements. Here are the top questions about BPOM license applications to help guide your next steps.

What happens if documentation is incomplete or incorrect?2025-01-08T10:49:30+08:00

Incomplete or incorrect documentation can result in delays, additional BPOM queries, or rejection of the application. It is crucial to review and double-check all submissions to avoid such issues.

What are the best practices for a successful BPOM application?2025-01-08T10:49:31+08:00

Key best practices include:

  • Ensuring the client has an E-FIN for PSP Online access.
  • Preparing accurate and complete documentation.
  • Conducting pre-submission testing for compliance.
  • Meeting packaging and labeling standards.
  • Partnering with experienced consultants to minimize errors and delays.
Can a service provider manage the BPOM application on behalf of the client?2025-01-08T10:49:31+08:00

Yes, a service provider can manage the process, but they need authorization through a Power of Attorney. The client must still provide their E-FIN and necessary documentation to facilitate the application.

What are the timelines for obtaining a BPOM license?2025-01-08T10:49:31+08:00

Timelines depend on the product category:

  • Food products: 1–2 months.
  • Cosmetics: 1–1.5 months.
  • Health supplements: 2–3 months.
  • Pharmaceuticals: 6–12 months or longer.
What documents are needed for BPOM license applications?2025-01-08T10:49:31+08:00

Required documents vary by product category but generally include:

  • Company documents (e.g., NIB, GMP certification).
  • Product details (e.g., specifications, composition, manufacturing process).
  • Packaging and labeling designs in Bahasa Indonesia.
  • Laboratory results and Certificate of Analysis (CoA).
  • Import documentation (if applicable).
Is a warehouse required for BPOM licensing?2025-01-08T10:49:31+08:00

Yes, a registered warehouse is mandatory for BPOM license applications. It must meet BPOM standards and serve as the official storage location for the products. Clients must provide documentation confirming the warehouse’s location and compliance.

Does the service provider or the client need the E-FIN for a BPOM application?2025-01-08T10:49:31+08:00

The client needs the E-FIN to register and access PSP Online. A service provider can handle the application process on the client’s behalf, but they will need the client’s E-FIN and a Power of Attorney (Surat Kuasa) to access the platform.

What is an E-FIN, and why is it needed for BPOM licensing?2025-01-08T10:49:31+08:00

An E-FIN (Electronic Filing Identification Number) is essential for businesses to access BPOM’s PSP Online platform. It links the client’s NPWP (Taxpayer Identification Number) to regulatory systems, enabling submission and tracking of BPOM applications.

Why is BPOM licensing important?2025-01-08T10:49:31+08:00

BPOM licensing is mandatory for businesses introducing food, cosmetics, pharmaceuticals, health supplements, or traditional medicines in Indonesia. It ensures products comply with safety, quality, and labeling standards, allowing them to be legally sold and distributed.

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